ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF): ALK's partner in North America, Merck (NYSE: MRK), known as MSD outside the USA and Canada, presents new data from a Phase IIb trial with its investigational sublingual house dust mite allergy immunotherapy tablet at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, USA.
The trial results showed that both doses of active treatment significantly reduced the average total nasal symptom score compared to placebo in adults with house dust mite-induced allergic rhinitis.
Merck has issued a news release concerning the findings from the clinical trial. The release is enclosed in full length on the following pages. Alternatively, it can be found on www.merck.com.
House dust mite allergy is the most prevalent allergy-induced respiratory disease in the world. The global develop programme for the investigational sublingual house dust mite allergy immunotherapy tablet covers three major markets: In Europe, ALK has announced positive outcome from two pivotal Phase II/III trials and plans for regulatory filing in 2014. In Japan, Torii is expected to announce results from two pivotal Phase II/III trials in 2014. In North America, Merck plans to continue with the clinical development and initiate a Phase III trial in 2014.
This announcement does not change ALK's outlook for the financial year 2014.
ALK-Abelló A/S
For further information please contact: Jens Bager, President and CEO, tel. +45 4574 7576 Investor Relations: Per Plotnikof, mobile +45 2261 2525 Press: Martin Barlebo, tel. +45 4574 7901, mobile +45 2064 1143
About ALK ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is the world leader in allergy immunotherapy - a unique treatment of the underlying cause of allergy. The company has approximately 1,800 employees with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Merck and Torii to commercialise sublingual allergy immunotherapy tablets in North America and Japan, respectively. The company is headquartered in Hørsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find more information at www.alk.net.
About the partnership with Merck in North America ALK has entered into a strategic partnership with Merck to develop, register and commercialise a portfolio of sublingual allergy immunoterapy tablets against grass pollen, ragweed and house dust mite allergy in the USA, Canada and Mexico. Under the agreement, ALK will receive up to DKK 1.6 billion (USD 290 million) in milestone payments from Merck, of which, approximately DKK 300 million has already been recognised in the years 2007-13. In addition, ALK is entitled to royalty payments on the net sales of the products on the North American market as well as payments for product supply. Merck will be responsible for all costs of clinical development, registration, marketing and sales of the products on the North American markets. ALK will be responsible for tablet production and supply.
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